Entire Transcript in Adobe Acrobat Format - National Reference ...

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legislating this. So the provisions of the 1974 Research
Act were limited.
It, of course, established the National
Commission to study this area but beyond that it
established the firm requirement that regulations would be
issued that would have informed consent and prior review
through an Institutional Review Board and it also made
clear that the department had the responsibility to provide
consultation and education on the subject.
(Slide.)
The National Commission recommendations which
were all forthcoming by 1978 were largely adopted. Of
course, children and the mentally infirmed,
institutionalized and mentally infirmed were not accepted.
The children were later and much more recently adopted.
These became the basis for the 1981 regulations
which are really the framework that we still have.
The President's Commission recommended the
Common Rule on Human Subjects for protection from all the
20 plus agencies that support such research and that
occurred in 1981. A decade later for reasons that Joan
Porter nicely surveyed for us that Common Rule was finally
published in the Federal Register and one of the things we
are still studying is the difficulty in having it truly be